Enteral feeding system

Abstract

A dispensing cap includes a gripping body, a spout engaging aperture, and a dispensing coupler. The dispensing coupler has a dispensing cap coupled thereto by a tether. Also disclosed is a bag assembly and a method of enteral feeding with a bag and a dispensing cap attachable to a spout. The dispensing cap can be provided and attached to the spout of the bag (upon removal of a fill cap), wherein the dispensing cap can be provided in a sterile packet or bag prior to use. Methods and processes are also disclosed.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 066,486, filed August 17, 2020, entitled “Enteric Feeding System,” the entire specification of which is incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to an enteral feeding system, and more specifically to a cap for a bag that can be used for enteral feeding, a bag having a cap that can be used for enteral feeding, and a method of using the cap for the bag. Background Technology

[0004] Enteral feeding is well known in the art. Depending on patient, environmental and other considerations, enteral feeding is used to directly feed patients by feeding them directly or indirectly into the stomach through a feeding tube, for example, that can be dispensed from a package or syringe.

[0005] One such example is feeding infants, often premature ones. Typically, the user draws a certain volume of real or artificial breast milk (i.e., formula, etc.) into a syringe, which is then connected to a feeding tube. While such a solution successfully delivers nutrition to the infant's stomach, it has drawbacks.

[0006] In many cases, the container (from which the syringe draws the fluid) has a relatively large opening, allowing contaminants and dirt to enter. Furthermore, such contaminants, even when present with air or oxygen, can cause oxidation of the milk fat and other substances. Often, the container is used for a whole day or longer, undergoing multiple feedings. In other cases, it is prone to spillage or other damage or spoilage of the dispensed fluid.

[0007] While not limited to this, there is also a desire to simplify compliance with closed systems, aseptic dispensing, and storage-resistant products that facilitate the dispensing of human milk (and other liquids, etc.). Summary of the Invention

[0008] This disclosure relates to a dispensing cap including a gripper, a nozzle engagement orifice, and a dispensing connector. The dispensing connector has a dispensing cap that is connected to the gripper via a strap.

[0009] In another aspect of this disclosure, the disclosure relates to a bag assembly including a bag and a dispensing cap. The bag has: a bag body defining a volume; and a nozzle providing communication with the volume. The dispensing cap is attachable to the volume and has a dispensing connector, to which the dispensing cap is connected by a strap.

[0010] In another aspect of this disclosure, the disclosure relates to a method of intestinal feeding using a bag and a dispensing cap that can be attached to a nozzle.

[0011] In another aspect of this disclosure, the present disclosure relates to a bag assembly including a bag and a dispensing cap. The bag includes a bag body that is flexible and defines a volume, and a nozzle provides fluid communication with the volume. The dispensing cap is fixedly engaged with the nozzle. The dispensing cap includes a gripper, a nozzle engagement orifice, a nozzle engagement end, and a dispensing connector. The gripper has an outer surface. The nozzle engagement orifice is structurally configured to engage the nozzle. The nozzle engagement end extends from the orifice and has an outlet opening that is in fluid communication with the nozzle and, consequently, with the volume. The dispensing connector extends from the nozzle engagement end and is in fluid communication with the outlet opening.

[0012] In some configurations, the assigning connector includes the EnFit connector.

[0013] In some configurations, the dispensing cap also includes a dispensing cover that can be positioned to cover the dispensing connector.

[0014] In some configurations, the component also includes a tether that is attached to the gripper at a first end and to the distribution cap at a second end.

[0015] In some configurations, the cap also includes one of a finger or a finger pull ring that extends from the cap to facilitate disconnecting the dispensing cap from the dispensing connector. In some such configurations, a fragile seal is configured to retain the dispensing cap on the dispensing cover.

[0016] In some configurations, the dispensing cap includes a flip-top cover that is connected to the gripper via a movable hinge mechanism.

[0017] In some configurations, the assembly also includes a biasing member that extends between the flip-top cover and the gripper to restrict the opening of the active hinge configuration.

[0018] In some configurations, the bag assembly also includes an outer flange extending from the nozzle engagement end. The flip-top cap includes an outer edge. The outer flange and the outer edge engage in the closure configuration.

[0019] In some configurations, the bag assembly includes at least one of a finger and a finger pull tab, which extend from the bag assembly to facilitate opening the flip-top cover around the movable hinge configuration.

[0020] In some configurations, the EnFit connector also includes an elongated orifice with an outer surface. The outer surface includes a truncated conical portion that extends from the nozzle engagement end and terminates at a beveled section.

[0021] In some configurations, the EnFit connector also includes a housing with inner and outer surfaces. The housing extends from the nozzle engagement end and surrounds the elongated orifice spaced apart from its outer surface. Threads extend around the outer surface of the housing.

[0022] In some configurations, the gripper also includes an annular clamp surrounding the nozzle engagement end. The annular clamp includes an annular wall, from which an upright wall terminating at an upper edge and including an outer surface along which a body thread is positioned. The bag assembly also includes a nipple assembly comprising a nipple member and a retaining ring. The nipple member includes a base flange and an upper funnel portion defining an upper opening and a lower opening. The retaining ring has: an upper wall having a lower surface; and a hanging wall hanging from the upper wall and including retaining threads. The retaining ring, cooperating with the annular clamp, clamps the nipple member between them while allowing fluid communication between the upper and lower openings and the outlet opening of the nozzle engagement orifice.

[0023] In some configurations, the annular hoop further includes: an inner wall that hangs from the annular wall; and an outer wall that hangs from the annular wall and is radially spaced from the inner wall. An inner connecting flange extends from the nozzle engagement hole to the inner wall.

[0024] In some configurations, the inner wall, the nozzle engagement hole, and the inner connecting flange define a groove extending around the nozzle engagement hole.

[0025] In some constructions, the outer wall of the retaining ring corresponds substantially to the outer wall of the annular hoop.

[0026] In some configurations, the bag assembly also includes a dispensing connector extending from the nozzle engagement end. The dispensing connector has an elongated orifice with an outer surface. The outer surface includes a truncated conical portion and a chamfered portion at the distal end of the truncated conical portion.

[0027] In some configurations, the distribution connector also includes a housing extending around the outer surface.

[0028] In some designs, human breast milk is placed in the volume of a bag.

[0029] In another aspect of this disclosure, a dispensing cap for attachment to a bag is provided. The dispensing cap includes a gripper, a nozzle engagement orifice, a nozzle engagement end, and a dispensing connector. The gripper has an outer surface. The nozzle engagement orifice is structurally configured to engage a nozzle. The nozzle engagement end extends from the orifice and has an outlet opening that communicates with the nozzle and, consequently, with a volumetric fluid. The dispensing connector extends from the nozzle engagement end and is in fluid communication with the outlet opening.

[0030] The assignment cap may include any feature or combination of features described above or herein.

[0031] In another aspect of this disclosure, the disclosure relates to a dispensing cap for attachment to a bag. The dispensing cap has a gripper, a nozzle engagement orifice, a nozzle engagement end, a dispensing connector, and a nipple assembly. The gripper has an outer surface. The nozzle engagement orifice is structurally configured to engage a nozzle. The nozzle engagement end extends from the orifice and has an outlet opening that communicates with the nozzle and, consequently, with a volumetric fluid. The dispensing connector extends from the nozzle engagement end and is in fluid communication with the outlet opening. The gripper also includes an annular clamp surrounding the nozzle engagement end, the annular clamp including an annular wall, an upright wall extending from the annular wall terminating at an upper edge and including an outer surface along which a body thread is positioned. The nipple assembly has a nipple member and a retaining ring. The nipple member includes a base flange and an upper funnel portion defining an upper opening and a lower opening. The retaining ring has an upper wall with a lower surface. A hanging wall hangs from the upper wall and includes retaining threads. A retaining ring that engages with the annular clamp clamps the nipple component between the two, while simultaneously allowing fluid communication between the upper and lower openings and the outlet opening of the nozzle engagement hole.

[0032] In some configurations, the annular hoop further includes: an inner wall that hangs from the annular wall; an outer wall that hangs from the annular wall and is radially spaced from the inner wall; and an inner connecting flange that extends from the nozzle engagement hole to the inner wall.

[0033] In some configurations, the inner wall, the nozzle engagement hole, and the inner connecting flange define a groove extending around the nozzle engagement hole.

[0034] In some constructions, the outer wall of the retaining ring and the outer wall of the annular hoop are essentially corresponding.

[0035] In some configurations, a dispensing connector extending from the nozzle engagement end is included, the dispensing connector having an elongated orifice with an outer surface comprising a truncated conical portion and a chamfered portion at the distal end of the truncated conical portion.

[0036] In some configurations, the distribution connector also includes a housing extending around the outer surface.

[0037] In another aspect of this disclosure, the present disclosure relates to a method of enteral feeding using a bag and a dispensing cap attachable to a nozzle. The method includes the steps of: providing a bag having a nozzle; attaching a dispensing cap to the nozzle; and attaching an external structure to the dispensing cap.

[0038] In some configurations, the dispensing cap includes an EnFit connector, and the external structure includes either a syringe or a feeding tube.

[0039] In some configurations, the method also includes a step of removing the filler cap before attaching the external structure to the distribution cap.

[0040] In some configurations, the step of attaching an external structure includes attaching the syringe to the dispensing cap.

[0041] In some configurations, the step of attaching an external structure includes drawing fluid from inside the bag into the syringe using a syringe.

[0042] In some configurations, the method further includes the step of suspending the bag in an inverted configuration on the outer structure after the step of attaching the outer structure to the distribution cap.

[0043] In some configurations, the external structure includes a feeding tube.

[0044] In some configurations, the external structure includes a nipple assembly.

[0045] In another aspect of this disclosure, the disclosure relates to a method of enteral feeding using a bag and a dispensing cap that can be attached to a nozzle, the method comprising the steps of: providing a bag having a nozzle and the bag having a volume filled with fluid; and attaching a dispensing cap having a nipple assembly as described above and below.

[0046] In some configurations, the method also includes the steps of: feeding the fluid to the patient; and discarding the dispensing cap and the bag with the nozzle after use.

[0047] This article discloses additional features, structures, methods, and processes, some of which relate to enteral feeding systems. Attached Figure Description

[0048] This disclosure will now be described with reference to the accompanying drawings, in which:

[0049] In the attached diagram Figure 1 This is a perspective view of bags having the dispensing caps of this disclosure, the perspective view specifically showing their connection;

[0050] In the attached diagram Figure 2 This is a perspective view of an exemplary bag used in conjunction with a dispensing cap and the enteral feeding system of this disclosure;

[0051] In the attached diagram Figure 3 This is a side view of an exemplary bag used in conjunction with a dispensing cap and the enteral feeding system of this disclosure;

[0052] In the attached diagram Figure 4 This is a cross-sectional view of an exemplary bag used in conjunction with a dispensing cap and the enteral feeding system of this disclosure, the cross-sectional view specifically showing the volume of the bag and the upper nozzle body of the bag's nozzle;

[0053] In the attached diagram Figure 5 This is a perspective view of an exemplary dispensing cap, which is structurally configured for use in conjunction with this enteral feeding system;

[0054] In the attached diagram Figure 6 This is a cross-sectional view of an exemplary dispensing cap attached to a bag structurally configured for use in conjunction with the enteral feeding system of this disclosure, the cross-sectional view showing fluid-communication channels for dispensing fluid from within the volume of the bag;

[0055] In the attached diagram Figure 7 This is a partial cross-sectional view of an exemplary dispensing cap attached to a bag, the dispensing cap being structurally configured for use in conjunction with the enteral feeding system of this disclosure, the partial cross-sectional view specifically showing the connection between the bag's nozzle and the nozzle engagement orifice and nozzle engagement end of the dispensing cap;

[0056] In the attached diagram Figure 8 This is a perspective view of another exemplary dispensing cap of the present disclosure attached to a bag, which shows an alternative construction of the gripper and an alternative dispensing connector having both an elongated hole and a shell, and it should be understood that in some constructions, such a construction may include a dispensing cap and a strap;

[0057] In the attached diagram Figure 9 yes Figure 8 A perspective cross-sectional view of an exemplary distribution cap of this disclosure is shown;

[0058] In the attached diagram Figure 10 This is a perspective view of another exemplary dispensing cap of the present disclosure attached to a bag, showing an alternative to the gripper and illustrating a flip-top cap in which the dispensing cap and strap are integrated into a movable hinge, such that the flip-top cap can be operated with one hand to open and close the flip-top cap, thereby allowing the other hand to be used to attach external structures (such as syringes or feeding tubes) to the dispensing cap.

[0059] In the attached diagram Figure 11 Is it like this? Figure 10 Another perspective view of an exemplary dispensing cap attached to a bag;

[0060] In the attached diagram Figure 12 It is a perspective view of an exemplary bag and a dispensing cap, wherein the dispensing cap is connected to a syringe that can draw fluid from the volume of the bag through the nozzle and the dispensing cap;

[0061] In the attached diagram Figure 13 It is a perspective view of an exemplary bag and a dispensing cap suspended in an inverted configuration from a hook or similar object, wherein the dispensing cap's dispensing connector is connected to a feeding tube;

[0062] In the attached diagram Figure 14 This is a front view of the bag, showing the nipple assembly constructed together with the bag;

[0063] In the attached diagram Figure 15 It is a 3D diagram of the dispensing cap and nipple assembly;

[0064] In the attached diagram Figure 16 It is a three-dimensional sectional view of the dispensing cap and nipple assembly;

[0065] In the attached diagram Figure 17 This is a cross-sectional view of the dispensing cap and nipple assembly;

[0066] In the attached diagram Figure 18 This is a three-dimensional view of the distribution cap, showing the upright wall of the auxiliary connector;

[0067] In the attached diagram Figure 19 This is a cross-sectional view of the distribution cap, showing the upright wall of the auxiliary connector;

[0068] In the attached diagram Figure 20 This is a cross-sectional view of another construction of the dispensing cap, which has an auxiliary connector and a nipple assembly, as well as a connector for additional dispensing.

[0069] In the attached diagram Figure 21 This is a cross-sectional view of another configuration of the dispensing cap, which has an auxiliary connector and a nipple assembly, as well as an additional dispensing connector;

[0070] In the attached diagram Figure 22 This is a cross-sectional view of another construction of the dispensing cap, which has a nipple assembly;

[0071] In the attached diagram Figure 23 yes Figure 22 A side view of the structure;

[0072] In the attached diagram Figure 24 This is another construction of the bag and dispensing cap, showing a separate seal and other features;

[0073] In the attached diagram Figure 25 This is another construction of the bag and dispensing cap, showing a separate seal and other features;

[0074] In the attached diagram Figure 26 Another construction of the bag and dispensing cap shows a movable hinge connecting to the flip-top cap;

[0075] In the attached diagram Figure 27 Another construction of the bag and dispensing cap shows a movable hinge connecting to the flip-top cap;

[0076] In the attached diagram Figure 28 Another construction of the bag and distribution cap shows a movable hinge connecting to the flip-top cap; and

[0077] In the attached diagram Figure 29 Another construction of the bag and distribution cap shows a movable hinge connecting to the flip-top cap. Detailed Implementation

[0078] Although this disclosure allows for many different forms of embodiments, specific embodiments are shown in the accompanying drawings and described in detail herein. It should be understood that this disclosure should be considered exemplary and not intended to be limited to the embodiments shown.

[0079] It should be understood that the same or similar elements and / or components may be represented by the same reference numerals throughout the accompanying drawings. Furthermore, it should be understood that the drawings are merely illustrative representations of the invention, and some components may have been modified to scale for clarity.

[0080] Now refer to the attached diagram, especially to... Figure 1 The image shows a bag 100 with a dispensing cap 10, which preferably forms an enteral feeding system. It is understood that the bag can be filled with infant formula, breast milk or other infant nutrition products or liquid or flowable materials, as well as meal replacements for infants, toddlers, and adults, typically in which a feeding tube can be used and / or is required for feeding. Such a bag, together with the dispensing cap, is contemplated as part of an enteral feeding system. One such system can be configured to provide feeding to infants (e.g., premature infants), while other uses are also contemplated. Among these other uses, the bag and dispensing cap can be used in enteral feeding systems for children and adults, as well as animals other than humans. In practice, these components are not limited to this use, but the system can be very effective for such applications.

[0081] Further reference Figures 2 to 4 Generally, bag 100 includes a bag body 102 and a nozzle 110. Such bags come in various sizes, for example, any size between two and fifteen ounces (although larger and smaller sizes may be considered depending on the specific application). The bag body 102 typically comprises a flexible structure defined by a plurality of panels 104, the panels 104 being joined together by seals 106 to define a volume 108. The nozzle 110 is coupled to the bag body to provide fluid communication with the volume 108 of the bag body. The bag body may be formed from a polymer film, which may comprise one or more layers of material co-extruded and / or laminated together. Such a film may include various treatments and may include metal foil or vapor-deposited metals or other elements.

[0082] More specifically, nozzle 110 includes a bottom flange 112 and an upright nozzle body 114. Nozzle 110 typically includes a rigid polymer member that seals to a panel or seam of the bag body. In the illustrated configuration, the nozzle includes a finned-seal nozzle that connects to the bag between opposing panels, aligned with the seam. Other nozzles are also contemplated, including nozzles that include, for example, a bag flange that seals to the inner or outer surfaces of one or more panels.

[0083] Some such bags are disclosed in U.S. Patent No. 9,751,677B2 to Fiere et al., though not limited to use with said bags. Other such bags are sold by Scholel IPN Corporation, located in Northlake, Illinois, under the names CeanPouch and CleanPouchAseptic. The foregoing is illustrative only and not intended to be limiting, as the use of other bags and containers is contemplated. Other containers contemplated for use include pillow-shaped containers.

[0084] Reference Figure 1 and Figures 5 to 7 The dispensing cap is generally shown as 10. The dispensing cap includes a gripper 12, a nozzle engagement orifice 14, a nozzle engagement end 15, a dispensing connector 16, a dispensing cap 18, and a strap 19. The gripper 12 includes an outer surface 20 and extends from a lower end 22 to an upper end 24. Typically, the dispensing cap comprises a monolithically molded polymer component; however, it is conceivable that the polymer component can be formed from multiple components and joined together by adhesion, welding, or other means. In one configuration, the gripper comprises a generally circular component with surface variations to form a hemispherical structure, petals, clover, etc. The gripper is generally symmetrical about the central axis of the dispensing cap with respect to the nozzle and typically has a structure extending sufficiently away from the central axis of the nozzle to allow the user to hold and rotate it relative to the nozzle (preferably without tools or external objects, but simply with the fingers). In other configurations, for example... Figure 8 and Figure 9 As shown, the gripper may include outwardly extending (in many cases radially outward) wings, etc., to provide a component on which a rotational force or torque can be applied. Such torque can be applied in either direction to rotate the distribution cap in either direction.

[0085] Refer again Figures 5 to 7 The nozzle engagement hole 14 includes an inner wall surface 30 extending from a lower end 32 to an upper end 34. The inner wall includes a nozzle attachment member, which, in the illustrated configuration, includes threads 37 configured to matingly engage threads 122 of the nozzle. It is understood that in other configurations, the nozzle attachment member may include additional bolting action to engage a corresponding structure on the upright nozzle body. In other configurations, the nozzle attachment member may include tabs or pawls capable of engaging a corresponding structure on the outer surface of the upright nozzle body.

[0086] The nozzle engagement end 15 includes an inner surface 40, an outer surface 42, an inner overhanging flange 44, a groove engagement flange 46, and an outlet opening 48. In the illustrated configuration, the nozzle engagement end includes a member having an inner surface 40 and an outer surface 42, which is substantially perpendicular to the central axis of the nozzle. The outlet opening 48 is centrally located and extends through the nozzle engagement end 15. In the illustrated configuration, the outlet opening is a single opening substantially centered on the central axis of the nozzle. Of course, variations are contemplated, including variations in the position, number, and shape of the openings.

[0087] The inner overhang flange 44 includes an inner surface 50 and an outer surface 52. The outer surface 52 abuts against the upright nozzle body surrounding the upper opening 116. In some configurations, the interface may include a sealing engagement between them. To facilitate mating between components, the lower end of the outer surface may be chamfered to facilitate engagement and minimize obstruction between components.

[0088] The groove engagement flange 46 hangs over the inner surface 40 of the nozzle engagement end 15. The groove engagement flange engages with the circumferential groove 120 of the nozzle 110 (and can engage sealably). It is understood that the groove engagement flange may be slightly inclined radially outward, such that engagement with the circumferential groove 120 pushes the groove engagement flange 46 in a radially outward direction to facilitate a slightly biased engagement and provide an enhanced seal between them.

[0089] The dispensing connector 16 is shown as including an outer surface 62 and an elongated aperture 60 extending through the dispensing connector. The outer surface 62 may include a truncated conical portion 64 and a beveled portion 66 at the upper end of the truncated conical portion to facilitate engagement with an external device. In the illustrated configuration, the cross-sectional area of ​​the elongated aperture 60 is larger than the cross-sectional area of ​​the outlet opening 48. In other configurations, the two may be matched or may be interchangeable. It should be understood that such a dispensing connector is referred to as an EnFit connector for the EnFit connection system. In the specific configuration shown, the EnFit connector includes a convex connection system. Such connectors are covered, for example, according to ISO 80369, and more specifically according to ISO 80369-3, the entire contents of which are incorporated herein by reference. It is understood that connectors other than EnFit, which is preferably used for enteral feeding, are also conceivable, and this disclosure is not limited to connectors such as EnFit.

[0090] In other constructions, for example Figure 8 and Figure 9The housing 80 may be constructed around the elongated aperture 60. In this construction, the housing 80 is generally concentric with the elongated aperture 60 and includes an inner surface 82 (radially spaced from the outer surface 62), an outer surface 84, a lower end 86, and an upper end 88. The upper end 88 terminates in a mating correspondence with the beveled portion 66. The outer surface 84 may also include attachment members 89, such as threads, which can matingly engage other external structures, such as feeding tubes, etc. Similarly, like the elongated aperture 60 of the dispensing connector 16, the housing may also be an EnFit connector of the EnFit connection system. Together, they form the male / female EnFit connector of the EnFit connection system. This construction is useful because it tends to become the standard for use throughout the enteral feeding system. It should be understood that the housing construction can be adapted to any other dispensing cap of this disclosure.

[0091] Reference Figures 5 to 7 Dispensing cap 18 is shown defining an orifice 68. Dispensing cap 18 is configured such that the elongated orifice of dispensing connector 16 can be sealed by dispensing cap. Dispensing cap 18 is attached to dispensing cap by a strap (e.g., strap 19) having a first end 70 at the gripper and a second end 72 at the dispensing cap.

[0092] As from Figure 5 Understandably, the gripper, dispensing cap, and strap 19 can all be integrally molded together. Therefore, it should be understood that when the cap is positioned over the elongated orifice, the strap has the flexibility to bend and resist returning to its original configuration. In other configurations, the strap 19 may comprise another material, such as a flexible rubber material, thread, or braided cable-like material.

[0093] In other constructions, refer to Figure 10 and Figure 11 The dispensing cover may include a flip-top cover 90, which is hinged to the gripper via, for example, a movable hinge configuration 91. Such a cover may include a larger cover 92 that, when in a closed configuration, engages matingly with the gripper and forms part of the gripper, and the cover 92 may flip open, for example, about the movable hinge, to open or close as needed. An aperture 68 may extend from the inner surface 94 of the larger cover 92. An additional restraining or biasing member 95 may be used to restrict the opening of the movable hinge configuration 91. The nozzle engagement end may include an outer flange 96, in which the outer flange 96 engages with the outer edge 97 of the flip-top cover 90.

[0094] In practice, for example, for enteral feeding of infants, a container, such as a bag, containing, for example, breast milk, formula, or other nutrients is provided to the user. Advantageously, in the bag construction disclosed above, this filling can be performed under aseptic conditions. In other constructions, for example, a distillation process can be utilized after filling. It should be understood that while this method is particularly useful as a system in an aseptic filling environment, it is not limited thereto.

[0095] First, in a sterile environment, typically, the bag or container will have a first cap installed during filling, and the dispensing cap 10 can be provided in a separate sterile package. The user can remove the dispensing cap 10 from the sterile package. Once removed, the user can remove the cap covering the bag 100. Once removed, the user can apply the dispensing cap 10 to the bag 100. The user can attach the dispensing cap 18 to the dispensing connector before attaching the dispensing cap to the bag to minimize the possibility of squeezing or otherwise damaging the bag, which could cause some contents to be lost through the nozzle. In the case of a flipped top cap, the cap can be in a closed orientation before and during its attachment to the nozzle.

[0096] Preferably, in order to attach the dispensing cap and remove another cap, the user can grasp and hold the nozzle, allowing the rest of the bag body to be free from contact and / or grasping.

[0097] Once the dispensing cap is attached to the nozzle, the user can connect the dispensing connector to an external structure. For example, refer to... Figure 12 The syringe 200 (having a connector that mates with the dispensing connector, such as, but not limited to, the EnFit connector) can be attached to the dispensing connector such that the internal volume of the syringe is in fluid communication with the elongated orifice 60, the outlet opening 48, and in turn with the volume 108 of the bag.

[0098] A retractable syringe is used to fill the bag's volume. For example, such a syringe can be filled with any amount between 2 ml and 35 ml, although larger or smaller filling volumes are also conceivable. Simultaneously, the bag volume can be reduced by pulling the fluid or by carefully compressing the bag. In some configurations, the bag can remain upright (with the nozzle above the bag body) or can be inverted so that the bag body is above the nozzle. Other configurations between these are also conceivable.

[0099] Once the required amount has been dispensed into the syringe, the user can disconnect the syringe. The user can then apply the dispensing cap 18 to the elongated orifice of the dispensing connector 16.

[0100] In other configurations, for example (but not limited to), a feeding tube with an EnFit connector can be directly attached to, for example, a dispensing cap. Figure 13An example of this is shown. Additionally, the bag can be raised so that it can be dispensed by gravity. In some such examples, the bag can be suspended in an elevated position by a hook or similar object to ensure that it can be dispensed directly into the feeding tube by gravity.

[0101] In any case, once completed, the user can disconnect the syringe, feeding tube, or other components from the dispensing cap 18 and reapply the dispensing cap to seal the bag's volume. The bag can then be stored, for example, in a refrigerator, without concern about product loss through the nozzle. Furthermore, because the bag volume can be reduced during dispensing, the entry of air or other fluids from the outside can be limited, further reducing the likelihood of introducing microorganisms or pathogens into the bag's volume.

[0102] Although the system can be used with other types of containers, its use with bags, pouches or other containers (the volume of which may vary) has the advantage of minimizing the ingress of fluids and gases during the dispensing process.

[0103] It should be understood that different types of dispensing connectors, different types of dispensing caps, and different types of straps can be varied and interchanged between different constructions to form a variety of different variations. Furthermore, the bags of this disclosure can be replaced by packaging with different constructions, including but not limited to flexible packaging. Additionally, the specific fluid contained within the bag can vary, and those fluids disclosed are provided as examples only and are not intended to be limiting.

[0104] For example, such as Figures 14 to 19 As shown, a nipple component (e.g., nipple component 240) can be attached to the nozzle 110. This configuration allows the nipple to be attached to the bag after it has been opened and the cap removed. While this is preferred, an integrated solution is also conceivable, in which the nipple can be mounted or permanently attached to the nozzle, and a protective cap can be positioned on the nipple.

[0105] In one illustrative, rather than limiting, construction, the dispensing cap includes a gripper 12 having a nozzle engagement hole 14 and a nozzle engagement end 15, an auxiliary connector 230, and a nipple assembly 222. As described in other constructions, the gripper provides a structure for the user to grasp and hold the dispensing cap. Figure 14 a to Figure 14In the construction of e, the gripper includes an annular clamp 202, which includes an upper end 22 and a lower end 24. The annular clamp 202 includes an inner wall 204, an outer wall 206, and an annular wall 208. The inner wall 204 is radially spaced from the nozzle engagement hole 14 and is connected to the nozzle engagement hole 14 by an inner connecting flange 210 spaced from the lower end 22 and the upper end 24 (and the inner connecting flange 210 is slightly inclined upward between the inner wall and the nozzle engagement hole to guide any fluid away from the nozzle engagement hole). In addition, this construction defines a groove around the nozzle engagement hole, which is formed by the outer surface of the nozzle engagement hole combined with the inner connecting flange 210 and the inner wall 204.

[0106] The outer wall 206 is spaced apart from the inner wall and connected to the inner wall via an annular wall 208. The annular wall 208 includes an upper surface 214. In the illustrated configuration, the outer wall is structurally corresponding to the overhang wall 280 or the nipple assembly, such that the two are substantially matched in diameter. Variations are of course conceivable; however, this configuration allows for selective simultaneous gripping of one or both of these structures as needed.

[0107] Preferably, the gripper is molded together with the nozzle engagement hole and the nozzle engagement end. In the illustrated configuration, the nozzle engagement hole substantially matches the aforementioned configuration described above. In the illustrated configuration, the nozzle engagement end terminates the nozzle engagement hole. The nipple assembly provides an alternative dispensing connector that is attached to the gripper via an auxiliary connector.

[0108] In the illustrated configuration, the auxiliary connector is formed together with the gripper 12 and includes an upright wall 230. In this configuration, the upright wall 230 is substantially parallel to and perpendicular to the inner and outer walls of the annular band. The upright wall extends upward away from the upper surface 214 of the annular band in a direction opposite to the inner and outer walls of the annular band. The upright wall 230 includes a lower end 232, an upper end 234 defining an upper edge, an inner surface 236, and an outer surface 238.

[0109] Nipple component 222 in Figures 14 to 21 Figure b shows a nipple component 240 and a retaining ring 260. The nipple component includes a flexible molded member (formed from a molded flexible polymer) 240, which includes a base flange 242 and an upper funnel portion 248. The base flange includes a top surface 244 and a bottom surface 246, and the upper funnel portion 248 extends from the base flange and defines a cavity 250. The cavity 250 has an upper opening 252 and a lower opening 254, the lower opening 254 being formed at or near the mating point of the base flange and the upper funnel portion. Of course, any number of different configurations are conceived for the upper funnel portion.

[0110] The retaining ring 260 includes an upper wall 262 and a cantilever wall 280. It is understood that the retaining ring is threaded onto the upright wall to clamp the nipple component (specifically, the base flange 242 of the nipple component) between them. The upper wall 262 of the retaining ring 260 includes a central opening 264, an outer perimeter 266, an upper surface 268, and a lower surface 270. The lower surface includes a lower block 272, which further facilitates a seal of the nipple component. The cantilever wall 280 includes an inner surface 282, an outer surface 286, and a lower end 189. The inner surface 282 includes threads that engage with the threads of the outer surface of the upright wall 230. The outer surface 286 includes gripping ribs 288 to facilitate a user's grip and manipulation of the retaining ring. The retaining ring may comprise a resilient molded polymer (and may be made of a polymer similar to, the same as, or different from the polymer forming the dispensing cap). Typically, the nipple component is made of a softer and more compressible material to allow for elastic deformation between the retaining ring and the upright wall.

[0111] It should be understood that although an opening is shown at the nozzle engagement end, in some configurations, another distributing connector 16 (e.g.) Figures 1 to 13 The outlet surface or housing of the nozzle can be additionally constructed on the nozzle engagement end. In such a construction, a single dispensing cap is capable of receiving the nipple assembly 222 or various types of EnFit connectors (as well as other structures and connectors). Figure 20 and Figure 21 Two such constructions are shown, each illustrating a different EnFit connector, one including an elongated aperture, and the other also including a housing. Figure 22 and Figure 23 In its construction, the upright wall 230 of the auxiliary connector may include an outer surface 238, which is conical and / or slopes inward toward the nozzle engagement hole, and this outer surface can compress the nozzle engagement hole to create a substantially fluid-tight engagement, thereby minimizing gaps through which fluid can pass. Additionally, the remainder of the body follows the profile of the nozzle to minimize additional gaps and improve dishwasher and / or cleaning performance of the nipple assembly, auxiliary connector, and dispensing cap.

[0112] It should also be understood that this nipple assembly can be for single use or disposable, so that the entire bag with the nipple assembly can be thrown away or discarded after use.

[0113] In other configurations, an integrated solution for the nozzle has been conceived, wherein the desired dispensing connector is on the dispensing cap and provides the dispensing cap during filling. In such a configuration, a press-fit seal 315 can be applied, and the dispensing cap can be fastened to the dispensing cap, and a separable seal 317 can be applied at the cap-body interface; this seal can be fragile and can break in a variety of different ways. One such configuration is... Figure 24 The image shows a flat, finger-shaped flange 320. Figure 25 The image shows a finger pull ring 322.

[0114] exist Figure 26 and Figure 27 Another such configuration is shown, illustrating a flipped top with a flat, finger-shaped connector. In this configuration, the inner sealing cylinder (i.e., orifice 68) can be press-fitted. The protrusion and groove 324 can be used to maintain a seal by engaging with the protrusion 326 on the dispensing cap. Additionally, a split seal 328 can surround the entire cap. Figure 28 and Figure 29 A similar construction with a pull ring is shown. It is understood that this construction can be used for a variety of different distribution connectors.

[0115] Among other advantages and features, the above disclosure provides a substantially closed system and enhances aseptic technique by protecting the contents and facilitating aseptic transfer when filling a syringe from a bag that can be filled with a sterile construction. Furthermore, this construction allows for the dispensing of fluid from a single container. The enteral feeding system of this disclosure, when used in the disclosed manner, complies with ADA and ASPEN guidelines regarding the aseptic handling of human breast milk. Additionally, it is conceivable that when filling the syringe, the dispensing cap protects the contents and facilitates aseptic transfer within the closed system. In the disclosed construction, the dispensing cap can be covered to provide a cost-effective, easy fluid transfer system, particularly compared to conventional transfer and extraction methods that, for example, can use multiple pipettes.

[0116] It should also be understood that at least some of the provisions of this disclosure are intended to limit or eliminate breast milk exposure to air, which can be very problematic when using conventional, simple, open containers. As is known in the art, common exposure to ambient air in the case of standard screw-tops and bottles can lead to the oxidation of milk fat and an accelerated rate of bacterial colonization within the fluid.

[0117] The foregoing description explains and illustrates this disclosure, and this disclosure is not limited to the foregoing description unless so defined by the appended claims, as those skilled in the art who have read this disclosure will be able to make modifications without departing from the scope of this disclosure.

Claims

1. A bag assembly comprising: - A bag having: a bag body that is flexible and defines a volume; and a nozzle that provides fluid communication with the volume; - A dispensing cap, which is fixedly connected to the nozzle, the dispensing cap comprising: - A gripper having an outer surface; - Nozzle engagement hole, which is structurally configured to engage the nozzle; - A nozzle engagement end extending from the nozzle engagement orifice and having an outlet opening communicating with the nozzle and, consequently, with the volumetric fluid; and - A dispensing connector extending from the nozzle engagement end and in fluid communication with the outlet opening. in: - The gripper further includes an annular clamp surrounding the nozzle engagement end, the annular clamp including an annular wall, an upright wall extending from the annular wall terminating at an upper edge and including an outer surface along which a body thread is positioned; and - The bag assembly further includes a nipple assembly, which includes: - A nipple component including a base flange and an upper funnel portion defining an upper opening and a lower opening; and - A retaining ring having an upper wall with a lower surface; and - A cantilever wall that hangs from the upper wall and includes retaining threads. - Wherein, the retaining ring, which cooperates with the annular clamp, clamps the nipple component between the two, while allowing the upper opening and the lower opening to be in fluid communication with the outlet opening of the nozzle engagement hole.

2. The bag assembly according to claim 1, wherein, The annular hoop further includes: an inner wall that hangs from the annular wall; an outer wall that hangs from the annular wall and is radially spaced from the inner wall; and an inner connecting flange that extends from the nozzle engagement hole to the inner wall.

3. The bag assembly according to claim 2, wherein, The inner wall, the nozzle engagement hole, and the inner connecting flange define a groove extending around the nozzle engagement hole.

4. The bag assembly according to claim 2, wherein, The outer walls of the retaining ring and the outer walls of the annular hoop are substantially matched in diameter.

5. The bag assembly of claim 1, further comprising a dispensing connector extending from the nozzle engagement end, the dispensing connector having an elongated orifice with an outer surface including a truncated conical portion and a chamfered portion at the distal end of the truncated conical portion.

6. The bag assembly according to claim 5, wherein, The distribution connector also includes a housing extending around the outer surface.

7. The bag assembly according to claim 1, wherein, The bag contains human breast milk.

Images